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Disaster Planning webinar offered by OLAW

Posted on February 28, 2013 by Matthew Tanner |

Disaster Planning: March 7, OLAW Webinar The Guide requires that institutions develop disaster plans that take into account both the well-being of animals and consideration of personnel during unexpected events that compromise ongoing animal care (See OLAW FAQ G3). Join…

FDA publishes final rule regarding 21 CFR Parts 50 and 56 regulating clinical trials and children

Posted on February 28, 2013 by Matthew Tanner |

The FDA published a final amended rule in the Federal Register on 02/28/2013 concerning 21 CFR Parts 50 and 56. The effective date of this rule will be March 28th, 2013. From the posting: Summary The Food and Drug Administration…

NC3Rs Annual 2013 3Rs Prize Awarded

Posted on February 28, 2013 by Matthew Tanner |

The NC3Rs annual 2013 3Rs Prize Awarded to Harvard researcher Dr. Ingber for his “lung on a chip” preclinical drug testing chip, designed to mimic normal lung function. The chip was designed to replace the need for an animal model…

Two policy documents released for public comment on Dual Use Research of Concern agents

Posted on February 27, 2013 by Matthew Tanner |

The government recentlty released two policy documents, regarding Dual Use agents, in response to a pair of articles detailing the increase in pathogenicity modification of H5N1 virus. The documents were announce in the Federal Register, one from the Office of…

2013 AVMA Guidelines for the Euthanasia of Animals published

Posted on February 26, 2013 by Matthew Tanner |

The AVMA has published a new set of “AVMA Guidelines for the Euthanasia of Animals”, 2013 edition, to replace the 2007 edition. The full document is available here (Note: large pdf file). From the executive summary: HISTORY OF THE PANEL ON…

Protections for Subjects in Human Subjects Research with Pesticides: Final Amendments to EPA’s 2006 Rule Strengthen Protections

Posted on February 22, 2013 by Matthew Tanner |

Final Amendments to EPA’s 2006 Rule Strengthen Protections On February 8, 2013, EPA Administrator Lisa P. Jackson signed amendments strengthening existing standards for human research involving pesticides submitted by third parties for consideration in EPA decision-making. The amendments apply to…

Notice of Change to Electronic Submission of Final Noncompliance Reports to the Office of Laboratory Animal Welfare

Posted on February 22, 2013 by Matthew Tanner |

From the NIH/OLAW: Federal Register: NOT-OD-05-034 This Notice is to inform Public Health Service (PHS) awardee institutions that the NIH Office of Laboratory Animal Welfare (OLAW) is transitioning to electronic submission of final noncompliance reports instead of paper submissions by…

MOU’s and Collaboration

Posted on February 9, 2013 by Matthew Tanner | 0 Comments

Recently, OLAW (NIH/DHHS) signed a Memorandum of Understanding (MOU) with the Offices of Research Oversight and Research and Development of the VA regarding laboratory animal welfare. The purpose of these types of high-level agreements is many fold, but primarily to…

European Medicines Agency updates guideline on evaluation of anticancer medicines

Posted on January 16, 2013 by Matthew Tanner |

From the EMA: 11/01/2013 The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as an integrated part of the development of…

Introspective Reporting and Building a Smarter eIRB

Posted on January 12, 2013 by InfoEd Global |

One of my favorite things to do when I worked in the IRB was reporting. Not simply the “How many Protocols do we have and sort that into Full, Expedited and Exempt categories” but the kinds of queries that told…